Pretension Plus 80/12.5mg Dasan Treatment Treatment for high blood pressure (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Telmisartan, hydrochlorothiazide
Ingredient
| Composition information | Content |
| Telmisartan | 80mg |
| Hydrochlorothiazide | 12.5mg |
Uses
Indications
pretension plus are indicated for high blood pressure treatment.
This combination is not indicated for the original therapy (see the dose and usage).
Pharmacokology
hydrochlorothiazid:
hydrochlorothiazid and thiazid diuretics increase the secretion of sodium chloride and water attached to the mechanism of inhibiting the reabsorption of sodium and chlorine ions in the distance. The excretion of other electrolytes also increases, especially potassium and magnesi, and calcium decreases.
hydrochlorothiazid also reduces the activity of carbon dioxide, so it increases the secretion of bicarbonate but this effect is usually small compared to the excretion effect and does not significantly change the urine pH. Thiazids have a moderate diuretic effect, because about 90% of sodium ions have been reabsorbed before arriving in the distance is the main position of the drug.
hydrochlorothiazid has the effect of lowering blood pressure, firstly due to a decrease in plasma volume and external fluids related to sodium secretion. Then, during the use of the drug, the effect of lowering blood pressure depends on the decrease in peripheral resistance, through the gradual adaptation of blood vessels from the reduction of Na+concentration. Therefore, the hypotension effect of hydrochlorothiazid is shown slowly after 1-2 weeks, while the diuretic effect occurs quickly and can be seen right after a few hours. Hydrochlorothiazid increases the effects of other antihypertensive drugs.
telmisartan:
Termisartan is a specific antagonist of Angiotensin II receptor (type at,) in the smooth and adrenal muscle.
In the renin-ankiotensin system, angiotensin II is made up of angiotensin I thanks to the catalyst of the enzyme transferring angiotensin (ACE). Angiotensin II is a vascular contraction, stimulating synthetic adrenal shells and releasing aldosteron, stimulating heart.
Aldosteron reduces sodium secretion and increases the excretion of potassium in the kidneys.
Telmisartan prevents mainly Angiotensin II into the AT1 receptor, in the blood vessel and adrenal glands, causing vasodilation
and reduce the effects of aldosteron. The AT2 receptor is also found in many tissues, but it is unclear whether this receptor is related to the cardiovascular stability. Telmisartan has a strong affinity for AT1 receptor, 3,000 times higher than the AT2 receptor.
Unlike the Angiotensin transferring enzyme inhibitors - the group of drugs is widely used to treat hypertension, Angiotensin II receptor antagonists do not inhibit bradykinin, so they do not cause persistent dry cough - an effect
Unwanted desire is common when treated with ACE inhibitors. Therefore, Angiotensin II receptor antagonists are used for those who have to stop using ACE inhibitors because they persist.
In humans, the dose of 80mg Telmisartan inhibits almost completely hypertension due to angiotensin II. Inhibiting effects (hypotension) are maintained for 24 hours and still measures 48 hours after drinking. After taking the first dose, the effect of reducing blood pressure manifests itself slowly within the first 3 hours. Typically, the maximum reduction of arterial blood pressure reached 4-8 weeks after the beginning of treatment.
Prolonged effects when long -term treatment. In hypertension people, Telmisartan reduces systolic and diastolic blood pressure without changing the heart frequency. Telmisartan's anti -hypertension effect is equivalent to other anti -hypertension drugs.
When stopping treatment of Telmisartan suddenly, the blood pressure again gradually again for a few days as not yet treated, but there is no strong increase in the phenomenon.
pharmacokinetics
hydrochlorothiazid:
After taken, hydrochlorothiazid is relatively fast, about 65 - 75% of the dose of use, but this ratio may decrease in heart failure people. Hydrochlorothiazid accumulated in red blood cells. The drug excreted mainly through the kidneys, largely in the form of non -metabolic. Half of the lifetime of hydrochlorothiazid is about 9.5 - 13 hours, but may last in the case of renal failure so the dose adjustment should be adjusted. Hydrochlorothiazid passes through the placenta, distributed and reached high concentrations in the fetus.
Diuretelli effects appear after drinking 2 hours, reaching maximum after 4 hours and lasting about 12 hours.
Anti -hypertension effect is much slower than diuretic effects and can only achieve adequate effect after 2 weeks, even with the optimal dose between 12.5 - 25 mg/day. It is important to know that the anti -hypertension effect of hydrochlorothiazid is usually optimal at a dose of 12.5 mg (half of 25mg). Modern clinical treatment and clinical trial guidelines emphasize the lowest and optimal use of doses, which reduces the risk of harmful effects. The important issue is to wait enough time to assess the body's response to the hypotension effect of hydrochlorothiazid, because the effect on the peripheral resistance takes time to be clear.
telmisartan:
Telmisartan is rapidly absorbed through the gastrointestinal tract. Absolute oral bioavailability depends on the dose: about 42% after taking the dose of 40mg and 58% after drinking 160mg. The presence of food reduces the bioavailability of Telmisartan (down about 6% when using a dose of 40mg). After drinking, the highest drug concentration in plasma is achieved after 0.5 -1 hours.
more than 99% of Telmisartan attaches to plasma proteins mainly on albumin and A -ACID glycoprotein. The attachment to protein is constant, not affected by the change of dose. The distribution volume is about 500 liters.
After intravenous injection or taking Telmisartan, most of the given doses (more than 97%) are eliminated in a constant form
honey into the feces, only very small amount (less than 1%) discharged through the urine. Telmisartan's half-life is about 24 hours, the bottom ratio of Telmisartan is about 15-20%. Telmisartan is converted into an uninfected acylglucuronide, only seen in plasma and urine. Telmisartan with recommended dose does not cause significant clinical accumulation.
Telmisartan's pharmacokinetics in children under 18 have not been studied. There is no difference in mobility in the elderly and people under 65 years old. Telmisartan concentration in women's plasma is usually 2-3 times higher than men, but does not see increased significance about response to blood pressure or lowering hypotension standing in women. So do not need to adjust the dose.
Mild and medium renal failure: No dose adjustment. Dialysis has no effect to eliminate Telmisartan.
Hepatic failure: Telmisartan concentration in blood increases and absolutely bioavailable reaches nearly 100%.
Before taking Pretension Plus 80/12.5mg Dasan Treatment Treatment for high blood pressure (3 blisters x 10 tablets)
How to use
Take oral use.
Dosage
Alternative therapy
This form of combination can be replaced for the titration ingredients.
Standard dose according to clinical effect:
Pretension Plus tablets are tablets containing both Telmisartan 40mg and hydrochlorothiazid 12.5mg; Or Telmisartan 80mg and hydrochlorothiazid 12.5mg. A patient whose blood pressure is not fully controlled with single therapy Telmisartan 80mg can be transferred to pretension plus tablets containing Telmisartan 80mg and hydrochlorothiazid 12.5mg once a day, and eventually increases the dose to 160/25mg if necessary.
Patients with adequate blood pressure with 25mg once daily with hydrochlorothiazid can switch to Telmisartan and hydrochlorothiazid (Telmisartan 80mg/hydrochlorothiazide 12.5mg), once a day. Clinical response to Telmisartan and hydrochlorothiazid should be evaluated and if the blood pressure is still not controlled after 2-4 weeks of treatment, the dose can be adjusted to 160/25mg if necessary. Patients are controlled by 25mg of hydrochlorothiazid but have hypoglycemia with this dosage mode, which can be transferred to Telmisartan and Hydrochlorothiazid (Telmisartan 80mg/hydrochlorothiazid 12.5mg), once daily, reducing hydrochlorothiazid dose without reducing the anticipation response to expectation.
Patients with renal failure:
conventional dose mode with Telmisartan and hydrochlorothiazid for patients with creatinine clearance> 30ml/min.
In patients with severe renal impairment, diuretics are more suitable than thiazid, so Telmisartan and hydrochlorothiazide are not recommended.
Patients with liver failure:
Telmisartan and hydrochlorothiazid are not recommended for patients with severe liver failure. Patients with biliary disorders or liver failure should have treatment begins under strict control of health with a combination dose of 40/12.5 (see caution).
What to do when overdose?Telmisartan
Data available related to Telmisartan overdose is limited. The manifestations of overdose with Telmisartan will be lower pressure, dizziness and tachycardia, slow heart rate may also appear from sympathetic stimulation (vagus nerve).
If the symptoms of low voltage appear, supportive treatment should be done, Telmisartan is not eliminated by blood separation.
hydrochlorothiazide
The most common signs and symptoms observed in these patients are drugs that cause electrolytes (hypotension, hypoglycemia, hypotension) and dehydration due to excessive diuretic. If Digitalis is also used, hypotension can increase arrhythmia. The degree of hydrochlorothiazid by blood separator has not been set. The oral dosage of hydrochlorothiazid is greater than 10g/kg on both mice and mice.
What to do when forgetting a dose?
Side Effects
Telmisartan and hydrochlorothiazid have been assessed for safety over 1700 patients including 716 patients who are treated for more than 6 months and 420 patients for more than 1 year. In clinical trials with Telmisartan and hydrochlorothiazid, there is no unexpected side effect to be observed. The experience of side effects is also limited to those who have previously been reported with side effects with telmisartan and/or hydrochlorothiazid. The general frequency of the side effects reported with this combination is compared to the placebo. The common side effects are light and transient and do not require stopping treatment.
Side effects appear at a ratio of 2% or more in patients treated with telmisartan/hydrochlorothiazid and at a higher rate than patients with fake treatment, regardless of the cause relationship, presented in Table 1.
| Telm (n = 209) (%) tired* The face diarrhea The following side effects are reported at a ratio of less than 2% in therapy patients with telmisartan/hydrochlorothiazid and at a higher rate than patients with placebo: back pain, indigestion, vomiting, tachycardia, hematuria, bronchitis, sore throat, rash, vertical hypotension, abdominal pain. Finally, the following side effects are reported at a ratio of 2% or more in therapy patients with telmisartan/hydrochlorothiazid, but equal or more common in the placebo group: pain, headache, cough, urinary tract infections. Side effects appear at the same or the same ratio between men and women, the elderly and young people, black and other skin -colored patients. In control tests (n = 1017), 0.3% of patients with telmisartan and hydrochlorothiazide with 40/12.5mg content; 80/12.5 mg or 80/25 mg has stopped therapeutic due to hypotension, and the rate of dizziness corresponding to 4%, 7%and 1%. telmisartan Other side effects have been reported to Telmisartan, which is not related to the relationship-results, listed below: hydrochlorothiazide Other side effects have been reported to hydrochlorothiazid, which is not related to the relationship-results, which is List below: The following side effects are seen during the time after approving the use of Telmisartan. Because these side effects are voluntarily reported from an uncertain number of patients, these side effects are often not established with firm frequency or setting associated with drug exposure. The decision to classify the reactions based on the characteristics of one or more factors: (1) The severity of the reaction, (2) the frequency of reporting, or (3) the level of relationship relationship with the Temisartan. Side effects are spontaneously reported with the most common frequency include: headache, dizziness, weakness, cough, nausea, fatigue, weakness, edema, face edema, nervous veins, urticaria, sensitivity, sweating, red rash, chest pain, atrial fibrillation, congestive heart failure, myocardial infarction, increased blood pressure, severe hypertension, hypoglycemia, hypoglycemia, hypoglycemia, diarrhea, diarrhea. Pain, urinary tract infections, erectile dysfunction, back pain, muscle contraction (including leg cramps), muscle pain, slow heartbeat, eosinophilia, plateletic decline, uric acid hyperkemis, liver dysfunction, renal failure including acute renal failure, anemia, anaphylaxis, anaphylactic reaction, and ligament pain (including tendon pain, tendonitis). A few cases of rare muscle pattern have been reported in patients with angiotensin II receptor inhibitors including Telmisartan tablets. Clinical laboratory findings: In control tests, changes related to the loneliness of standard laboratory testing parameters rarely related to the use of Telmisartan and hydrochlorothiazide tablets. Hemoclasses and hemocl There are hemocl There are hemocl There are hemocl There are over 1.2% and 0.6% of patients using Telmisartan/Hydrochlorothiazide, corresponding to control tests. Change of hematoma and the ratio of hemocl There are not considered significant clinical significance and no need to stop drugs due to anemia. Creatinine, Nitrogen urea (Bun): Bun (≥ 11.2 mg/dl) and serum creatine (≥ 0.5 mg/dl) have been observed on 2.8% and 1.4% of idiopathic turbocharged patients with Telmisartan in clinical trials. There are no patients who stop therapeutic with Telmisartan due to Bun or Creatinin increase. Liver function tests: Sometimes liver enzymes and or serum bilirubin appear. No need to stop treating telmisartan/hydrochlorothiazide due to abnormal liver function. Serum electrolytes: see the "cautious" section. |
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Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Telmisartan and hydrochlorothiazid are contraindicated in patients sensitive to any ingredients of the drug.
Because the drug has a hydrochlorothiazid ingredient, it is contraindicated in patients with urinary retention or sensitive to other sulfonamide derivatives.
Pregnant women (3 months between and at the end of pregnancy); Severe liver failure, renal failure (
Warning:
The rate of mortality and incidence of infants and fetuses:
The drug directly works on the Rennin-Anotensin system can cause disease and death in newborns and fetuses when used for pregnant women. A few dozen cases have been reported in world documents in patients who are taking enzyme inhibitors. When detected, stop using telmisartan and hydrochlorothiazid as soon as possible.
Use the drug that works directly on the Rennin-Anotensin system during the 2nd and 3rd period of pregnancy is thought to be related to the lesions of the fetus and infants, including lowering, reducing infant skulls, urinary retention, renal failure recovered or non-recovery and death. Little amniotic fluid has also been reported, perhaps the result of reducing the kidney function of the fetus; Little amniotic fluid in this case is also thought to be related to the fetal limb shrink, the deformation of the skull and face, reducing the growth of the lungs.
Premature, underdeveloped in the uterus, and arterioscleros have also been reported, although it is not clear whether these symptoms are due to drug exposure.
For the first period of pregnancy, these side effects do not appear due to the exposure of the drug in the uterus but this exposure should also be limited. The mother with embryos and fetuses is exposed to Angiotensin II receptor receptor during the first period of pregnancy should be notified. However, when the patient is pregnant, the doctor should stop using telmisartan and hydrochlorothiazid immediately.
Rare (perhaps less than 1/1,000 pregnant women), will not be found to replace Angiotensin II receptor receptor. In these rare cases, mothers should be notified of potential dangers to their fetus, and checked by continuous ultrasound to assess the amniotic fluid environment.
If observations are deficient in amniotic fluid, Telmisartan and hydrochlorothiazid should be stopped when the drug is considered to be survived for the mother. Checking for fetal movements (CST), fetal health measurement (chromosome) or biological test (BPP) may be appropriate, depending on the fetal week of the fetus. Patients and doctors should be noted, although amniotic fluid may not appear until the fetus has not recovered.
Babies with a history of uterine exposure with Angiotensin II receptor antagonist should be strictly controlled in pressure, urinary discharge, hyperkalemia. If the urinary minimum appears, pay attention to measures to support blood pressure and kidney perfusion. Blood replacement or a separation may be required as a measure to reverse the lower pressure and/or replace the disordered kidney function.
A progressive toxic study has been conducted in mice with Telmisartan/Hydrochlorothiazide at the dose of 3.2/1.0; 15/4,7; 50/15,6; and 0/15.6 mg/kg/day. Although the form of combination at twice as high as the toxin appears (reducing significant weight increase) for the use of each drug, there is no increase in toxicity for the development of the workpiece.
Not observing the teratogenic effect when Telmisartan is used for pregnant mice at oral doses up to 50mg/kg/day and pregnant rabbits at oral doses up to 45mg/kg/day. In rabbits, the embryo death is related to the toxicity of the mother rabbit (reduced the increase in body weight and nutrition consumption) which have been observed at 45mg/kg/day (about 12 times the dose of 80mg is the maximum recommendation in humans (MRHD) based on Mg/M2].
In mice, Telmisartan dose of mother toxicity (reducing body weight increase and energy consumption) is 15mg/kg/day (about 1.9 times the maximum recommended dose in humans (MRHD) based on Mg/m2), using drugs during late pregnancy and breastfeeding, observing side effects on infants, including low -weight, weight loss, and weight loss, low weight loss, low weight and weight loss. Telmisartan has been seen in the fetus during the late pregnancy and in breast milk.
Do not observe the effects of progressive toxicity on mice and rabbits at the corresponding dose of 5 and 15mg/kg/day, about 0.64 and 3.7 times based on Mg/ml compared to the maximum recommended dose on Telmisartan's humans (80mg/day).
studies on hydrochlorothiazid have been conducted with mice and pregnant mice during the period of the main organs at the corresponding dose of up to 3000 and 1000mg/kg/day, showing no evidence of damage to the fetus.
Thiazid passes the placenta and appears in the umbilical cord blood. The fetus or infants are at risk of jaundice, thrombocytopenia, and other adverse reactions that have appeared in adults.
Hypotension in patients decreased volume:
Start anti-hypertension therapy in patients that the Rennin-Anotensin system is activated as patients with sodium lower or lowered internal volume, for example, patients are treated with strong diuretics, should be used carefully. These conditions should be adjusted before using Telmisartan and hydrochlorothiazid. Therapy should be started under the close supervision of the doctor (see the dose and how to use). If the lower pressure appears, the patient should be placed in the back and, if necessary, intravenously salted saline. Not contraindicated to continue using when there is a transient pressure, these cases can often continue treatment without any difficulties once the blood pressure is stable.
hydrochlorothiazid:
Hepatic failure: Thiazid diuretics should be used carefully in patients with progressive liver or liver disease, because of a small change in electrolyte balance and fluid can lead to liver coma.
Hypersensitive reaction: Hydrochorothiazid sensitive reaction may appear in patients with or without a history of allergies or bronchial asthma, more common in patients with such a history.
Systemic lupus: Thiazide diuretics is reported to be worse or activate the system lupus.
Lithi interaction: generally should not use lithium with thiazid (see caution, drug interaction, hydrochlorothiazid, lithium).
Sercouring myopia and secondary closed angle: hydrochlorothiazid, a sulfonamid, which can cause a specific reaction, leading to acute transparent nearsightedness and closed angle glauca. Symptoms include an acute onset of vision or eye pain and typical appears within hours to a few weeks after the beginning of the therapy. No angle glaucoma does not lead to permanent vision loss. The main therapy is to stop using hydrochlorothiazide as quickly as possible. Ready for surgery or medication may need to be considered if the pressure is uncontrolled. The risk factor for the development of acute angle glauca may include a person with a history of allergy to sulfonamid or penicillin.
Be cautious when using
serum electrolytes:
Telmisartan and hydrochlorothiazide:
In tests with combined therapeutic therapeutic therapy/hydrochlorothiazid, no patient uses a dose of 40/12.5mg; 80/12.5mg or 80/25mg has a decrease in potassium ≥ 1.4 Meq/l, and no patient has hyperkalemia.
constantly using the drug for hypokalemia appears during the use of a combination of telmisartan/hydrochlorothiazide. The absence of signs of changing serum potassium concentration may be due to the mechanism of opposite activity of telmisartan and hydrochlorothiazide on the excretion of potassium in the kidney.
hydrochlorothiazid:
Periodically identify serum electrolytes to detect an imbalance of electrolytes that may be performed at appropriate intervals. All patients who use thiazid therapy should be monitored with clinical signs of electrolyte imbalance: hypoglycemia, hypotension, alkaline infection and hypotension. Identifying electrolytes in urine and serum is especially important when patients vomit excessively or fluid transmission. Signs and warning symptoms of body and electrolyte imbalance, regardless of the cause, including dry mouth, thirst, weakness, indifference, drowsiness, restlessness, confusion, convulsions, muscle pain or cramps, muscle fatigue, lower pressure, urinary decrease, tachycardia and digestive disorders such as nausea and vomiting.
Interventions with sufficient electrolytes will also contribute to lowering potassium. Hypotension can cause arrhythmia and can also cause sensitivity or overcurrent of the heart's response to the malicious reactions of digitalis (for example, increasing ventricular stimulation).
Although the deficiency of chloride is mild and often does not need special treatment, except in the special case below (as in the case of a person with liver or kidney disease), the replacement of chloride may be required in metabolic contamination therapy.
Sodium-lowering can occur in patients with edema in hot weather, appropriate therapy is water limit, not salt control, except for some cases that rarely lower sodium hematoma. In fact, salt loss, appropriate alternative measures are selected therapy.
Hyperglycemia can occur or gout in some patients who are taking thiazid therapy.
For patients with diabetes adjusting the dose of insulin or oral blood glucose that may be required.
Hyperglycose hyperlemen may occur with thiazid diuretics. Therefore, potential diabetes can occur during thiazid therapy.
The anti -hypertension effect of the drug may increase in patients after removal of sympathetic nerve.
If the renal failure becomes clearly progressive, it is necessary to consider continuing or stopping diuretics.
Thiazid has been known to increase the secretion of magnesium in the urine, which can lead to blood magnity,
Thiazid can reduce calcium secretion in urine. Thiazid may cause mild or non -continuous hypercalcemia in the absence of disorders of calcium metabolism. Decimous hypercalcemia may be a sign of hyperpigmentation hyperplasia. Thiazid needs to stop treatment before conducting a parathyroid function test.
Increased cholesterol and triglyceride content may be related to therapy with thiazid diuretics.
Liver function impairment
telmisartan
Because Telmisartan is mainly eliminated by the secretion of bile, patients with bile congestion disorders or liver failure may have reduced clearance of the drug. Therefore, Telmisartan and hydrochlorothiazid should be used carefully in these patients.
Renal function
telmisartan
Change the kidney function as a result of the inhibition of the Rennin-Anotensin-Aldosteron system that can be predicted in some sensitive patients. In patients with renal function may depend on the operation of the Rennin-Anotensin-Aldosteron system (for example, severe congestive heart failure patients), therapeutic with angiotensin transfer inhibitors and angiotensin receptor inhibitors may be associated with progressive urinary and/or urea urban (rare) with acute kidney failure and/or death. Similar results can be shortened in patients with treatment with Telmisartan.
In studies of ACE inhibitors in patients with kidney artery stenosis on the one side or on both sides, the increased serum creatinine or blood nitrogen urea has been observed. Unusual use of Telmisartan in patients with kidney artery stenosis on the one side or on both sides but the same side effects with side effects see with ACE inhibitors should be predicted.
hydrochlorothiazide
Thiazid should be used cautiously in patients with severe kidney disease. In patients with kidney disease, thiazid can cause blood urea.
The accumulation of drugs can progress in patients with renal function.
Dual inhibition of Rennin-Anotensin-Aldosteron:
telmisartan
As a result of the inhibition of the Rennin-Anotensin-Aldosteron system, changing the renal function (including acute renal failure) has been reported.
Double inhibition of the Rennin-Anotensin-Ordosteron system (for example, due to an ACE inhibitors to an angiotensin II receptor antagonist) should strictly control the kidney function.
Ontarget test on 25,620 patients under 55 years of age with atherosclerosis or diabetes with target organs, random tests in patients with only Telmisartan, with Ramipril or combined form, and monitor patients for an average period of 56 months. Clinical spending related to cardiovascular death, myocardial infarction, stroke and heart failure must be hospitalized in patients using the form of combined Telmisartan and Ramipril is not better than the patient group only using single Telmisartan or single Ramipril.
Concomitance Telmisartan and Ramipril is simultaneously increasing the exposure of both RamIPril and Ramiprilat by an excess of about 2 (see caution, drug interaction).
Do not recommend simultaneous use Telmisartan and Ramipril.
Information for patients:
Pregnant women: Women's patients who are in their birth age should be learned about the consequences of exposure to drugs active on the Rennin-Anotensin system during the first, second and third pregnancy, and patients should also be known that for the first period of pregnancy, these side effects do not appear due to the exposure of the drug in the uterus but this exposure is also limited. These patients should be required to report pregnancy to the doctor as soon as possible.
Symptoms of pressure: Patients who are taking Telmisartan and hydrochlorothiazid pills should be warned that the spinning mind may appear, especially on the first day of treatment, and this symptom should be reported to the prescribed doctor. Patients should be informed that if fainting appears, should stop using Telmisartan and hydrochlorothiazide until you have consulted with your doctor.
All patients should be warned that drinking is not enough water, sweating too much, diarrhea, or vomiting can lead to excessive hypotension, with similar consequences and a reeling mind may occur.
Potassium supplements: Patients taking Telmisartan and hydrochlorothiazid patients should be notified that they do not use potassium supplements or alternative salts that contain potassium without referencing a prescribed doctor.
The effect of the drug on the ability to drive and operate machinery
When there is no specific report, the patient still needs to be notified of unwanted side effects they can encounter such as dizziness or sleepiness during Pretension Plus treatment. Therefore, be careful when driving or operating machinery.
Use drugs for women during pregnancy and lactation
No data.
Drug interaction
Telmisartan
Digoxin: When Telmisartan is used simultaneously with digoxin, increasing the average communal concentration of digoxin (49%) and increasing the groove (20%) has been observed. Therefore, it is recommended that digoxin levels should be controlled when starting to use, adjust and stop Telmisartan to avoid overdose or not enough Digitalis.
Lithi: Inchoise the serum lithium and toxin concentration that has been reported during use simultaneously lithium with angiotensin transferring enzyme inhibitors. There are also cases that are reported to Angiotensin II receptor antagonists including Telmisartan. Therefore, lithium should not be used with diuretics, do not recommend using lithium with telmisartan and hydrochlorothiazid.
Non-Stoid anti-inflammatory drugs include selective inhibitors of cyclooxygenase -2 (COX-2 inhibitors): In elderly patients, reducing intravascular volume (including cases of diuretics), or with drugs that damage kidney function, simultaneously used with NSAIDs, including selective inhibitors on COX-2, with antigen anti-receptor drugs, Telmisart, Telmisond Damage kidney function, including acute renal failure. These effects often recover. Periodic renal function control in patients who are using Telmisartan and NSAID therapy.
The lowering effect of Angiotensin II receptor antagonistic drugs, including Telmisartan, may be reduced by NSAIDs including COX-2 inhibitors.
Ramipril and Ramiprilat: simultaneously use Telmisartan 80 mg once a day and Ramipril 10mg once a day for healthy people to increase CMAX Hang Dinh and AUC of Ramipril, equivalent to 2.3 and 2.1 times, and increase CMAX and AUC of Ramiprilate, respectively 2.4 and 1.5 times. In contrast, CMAX and AUC of Telmisartan decreased by 31% and 16% respectively. When using Telmisartan and Ramipril simultaneously, the response may be larger because perhaps the extra pharmacological effect of combined drugs, and also because of the increase in the exposure of Ramipril and Ramiprilat in Telmisartan.
warfarin: Telmisartan is taken for 10 days, increasing the average groove concentration of warfarin; This reduction does not change the international standardization ratio (INR).
Other drugs: Concentrated with Telmisartan does not cause clinical interaction with acetaminophen, amlodipine, glibenclamid, simvastatin, hydrochlorothiazid or ibutrofen. Telmisartan is not metabolized by the Cytochrome P450 system and does not work on in vitro on the cytochrome P450 enzyme, except for some CYP2C19 inhibitors. Telmisartan is not considered to interact with cytochrome p450 enzyme inhibitors; It is also not thought to be interactive with drugs metabolized by cytochrome P450 enzymes, except that can inhibit the metabolism of drugs metabolized by CYP2C19.
hydrochlorothiazide
When used simultaneously, the following drugs can interact with thiazid diuretics:
Alcohol, barbiturat, or psychotropic drugs: Potential hypotension can appear.
Diabetes treatment (oral and insulin medication): may need to adjust the dose of diabetes treatment.
Other anti -hypertension drugs: added or potential effects.
cholestyramin and colestipol: The absorption of hydrochlorothiazid is reduced in the presence of anion exchange. Single dose of cholestyramin or colestipol plastic associated with hydrochlorothiazid and reducing the absorption of the drug from the gastrointestinal tract to 85% and 43% respectively.
corticosteroids, ACTH: increase the decline of electrolytes, especially potassium.
Hypertension amines (for example, norepinephrin): may reduce the response to hypertension amines but not enough to prevent them from using them.
Musculoskeletal, non -reducing pipes (for example, tubocurarin): may increase the response to muscle relaxants.
Lithi: generally should not be used with diuretics. Diuretics reduce lithium kidney clearance and increase the risk of lithium toxicity. Refer to the instructions of the lithium preparation before using these preparations with Telmisartan and Hydrochorothiazide.
Non-Stoid anti-inflammatory drugs: In some patients, the use of non-steroid anti-inflammatory drugs can reduce diuretic effects, increase sodium secretion and anti-hypertension of diuretics, reduce potassium and thiazid. Therefore, when Telmisartan and hydrochlorothiazid and non-purseoid anti-inflammatory drugs are used simultaneously, the patient should be strictly controlled to determine whether diuretic effects want to be achieved.
The ability to cause cancer, gene mutations and decline in fertility:
Telmisartan and hydrochlorothiazide
There are no studies on the ability to cause cancer, gene mutations, or fertility impairment conducted in combination with Telmisartan and hydrochlorothiazid.
.telmisartan
There is no evidence of cancer likely when Telmisartan is used in a mouse and mouse for 2 years. The highest dose is used for mice (1000 mg/kg/day) and copper mice (100mg/kg/day) calculated by mg/m, equivalent to about 59 and 13 times the maximum recommended dose on human (MRHD) of Telmisartan. Similar doses have been tested to provide the average system exposure to Telmisartan respectively> 100 times and> 25 times compared to the exposure of the system in the person using MRHD (80mg/day).
Genotoxic tests do not show any side effects related to Telmisartan in both genes or chromosome levels. These tests include Salmonella and E. Coli (AMES) mutation tests, genetic mutations with Chinese cricetus kangaroo cells, a genetic cell test with human lymphocytes, and a mouse reproductive test
There is no effect on drugs on the reproduction of female and male mice that are noted at the dose of 100mg/kg/day (the highest dose), about 13 times, the province is mg/m ', the willow MRHD of Telmisartan. This willow on the mouse for the exposure of the average system (AUC Telmisartan is determined on the 6th day of pregnancy) at least 50 times the exposure of the average system in humans with MRHD doses (80mg/day).
hydrochlorothiazide
A study on mice and a 2 -year -old pills were conducted under the auspices of the National toxicity program (NTP) showed that there was no evidence of the ability to cause cancer of hydrochlorothiazid in female mice (at the dose to approximately 600mg/kg/day) or in female and male mice (at the dose to approximately 100mg/kg/day). However, the national toxic program (NTP) has seen evidence but is not clear about liver carcinom in mice.
Hydrochlorothiazid does not have genetic toxicity in the test tube in Salmonella Typhimurium mutant test Ta 98, Ta 100, Ta 1535, Ta 1537 and Ta 1538 and in the kangaroo ovaries test that Chinese cricetus on the wrong chromosome, or on the test tube in the test of mouse -mouse mouse cell chromosomes, Chinese cricetus mouse The sex of the fruit flies is deadly. The positive test results obtained in the clastogenicity test tube for Sister's chromosomes, on the mouse lymphocytic test (mutant), and on non -dissociation test Aspergillus tidulans.
hydrochlorothiazid has no side effects on the fertility of mice and mice of both gender in studies in which these species are exposed, through diet, at the corresponding doses of up to 100 and 4mg/kg, before mating and during pregnancy.
Pregnant women:
Type C (first 3 months) and d (between the three months and the last 3 months) (see the scene, the incidence of the disease, the death of the fetus/babies).
breastfeeding women:
Do not know if Telmisartan is excreted in breast milk, the Telmisartan is seen in the mouse's milk.
thiazid is found in human milk. Because the potential side effects on breastfed babies should calculate the decision to stop breastfeeding or stop taking the drug according to the importance of the drug with the mother.
Use for children:
Safety and efficiency in children have not been established.
Used in the elderly:
In control clinical trials (n = 1017), approximately 20% of patients are treated with telmisartan/hydrochlorothiazid or 65 or 5% of age. There is no overall difference in the safety and effectiveness of telmisartan/hydrochlorothiazid observed in these patients compared to young patients. Clinical experience is reported without any difference in response to the elderly and young people, but not excluding a few more sensitive elderly people.
Storage
Leave a cool place, avoid light, temperatures below 30⁰C.
To be out of reach of children, read the instructions carefully before use.
Other drugs
- ACICLOVIR 800MG TABLETS
- BETAHISTINE HYDROCHLORIDE 16MG TABLETS
- Protaphane
- PONSTAN FORTE 500MG TABLETS
- TERLIPRESSIN ACETATE 1 MG SOLUTION FOR INJECTION
- VOLTAROL 50 MG TABLETS
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